200831144 九、發明說明： 【發明所屬之技術領域】 大致上本發明係關於促進凝血之裝置，更特別係關於 發熱反應可經調節之止血劑以及結合此種止血劑之裝置。 【先前技術】 血液是一種液體組織，血液包括紅血球、白血球、小 體、及血小板分散於液相。液相爲血漿，血漿包括酸、脂 質、溶解之電解質及蛋白質。蛋白質懸浮於液相，蛋白質 可藉多種方法（諸如過濾、離心、電泳及免疫化學技術）中 之任一者而由液相中分離。一種懸浮於液相之特殊蛋白質 爲纖維蛋白原。當發生出血時，纖維蛋白原與水及凝血酶 (一種酵素）反應而形成纖維蛋白，纖維蛋白不溶於血液且 聚合而形成血凝塊。 於多種情況下，動物包括人類可能受傷。經常傷口會 造成出血。於某種情況下，傷口與出血輕微，故除了簡單 的急救之外只需要正常凝血功能。但不幸於其它情況下， 可能發生大出血。此種大出血情況通常需要特殊設備及器 材以及訓練有術的人員來施加適當的輔助。若不能取得此 等輔助，則可能出現血液過度流失。當出血嚴重時，偶爾 即刻取得設備及訓練有術的人員，仍然不足以即時阻斷血 液的流動。 但嚴重傷口經常係發生在遠方或發生於例如戰場等情 況，該等情況無法即刻取得適當的醫療協助。於此等情況 下，重要地必須停止出血，甚至於較不嚴重的情況下，需 200831144 要夠長時間奪ι行來允許受傷者或受傷動物獲得醫療照護。 試Η解決前文說明之問題，發展出於無法取得習知協 助或並非最佳有效協助之情況下用來控制過度出血的材 料。雖然此等材料顯示爲略微成功，但偶爾用於創傷傷口 不夠有效且價格昂貴。此外，此等材料偶爾於某些情況下 無效，難以施用且距離傷口部位遙遠。 另外或此外’先前發展出之材料產生非期望之副作 用。例如’一類型先前技術之凝血材料通常爲粉末或細小200831144 IX. INSTRUCTIONS OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention relates generally to a device for promoting coagulation, and more particularly to a hemostatic agent which can be adjusted for an exothermic reaction and a device incorporating such a hemostatic agent. [Prior Art] Blood is a liquid tissue including red blood cells, white blood cells, small bodies, and platelets dispersed in a liquid phase. The liquid phase is plasma, and the plasma includes acids, lipids, dissolved electrolytes, and proteins. The protein is suspended in the liquid phase and the protein can be separated from the liquid phase by any of a variety of methods, such as filtration, centrifugation, electrophoresis, and immunochemical techniques. A special protein suspended in the liquid phase is fibrinogen. When bleeding occurs, fibrinogen reacts with water and thrombin (an enzyme) to form fibrin, which is insoluble in blood and polymerizes to form blood clots. In many cases, animals, including humans, may be injured. Frequent wounds can cause bleeding. In some cases, the wound and bleeding are mild, so only normal blood coagulation is required except for simple first aid. But unfortunately in other cases, major bleeding may occur. This type of major bleeding usually requires special equipment and equipment as well as trained personnel to apply appropriate assistance. Excessive blood loss may occur if such assistance is not available. When bleeding is severe, occasional access to equipment and trained personnel is still not enough to immediately block the flow of blood. However, severe wounds often occur in distant locations or occur, for example, on the battlefield, where appropriate medical assistance cannot be obtained immediately. In such cases, it is important to stop bleeding, even in less severe cases, requiring 200831144 to take long enough to allow the injured or injured animal to receive medical care. Try to solve the problems described above and develop materials to control excessive bleeding in cases where conventional assistance is not available or is not optimally effective. Although these materials have been shown to be slightly successful, occasionally wound wounds are not efficient enough and expensive. In addition, such materials are occasionally ineffective in certain circumstances, difficult to apply and remote from the wound site. Additionally or alternatively, the previously developed materials produce undesirable side effects. For example, 'a type of prior art coagulation material is usually powder or small
W 微粒’當施用材料至出血部位時，材料的表面積經常產生 放熱反應。經常不必要地傾倒過量材料至傷口，造成放熱 效應的惡化。依據材料之特殊屬性而定，造成的放熱可能 足夠造成病人的不適或甚至發燒。雖然若干先前技術專利 案特別引述所造成的放熱反應爲期望的特徵，可對傷口產 生類似於燒烙的凝血效應，但仍然可能傷口部位組織及周 圍組織受到不良影響。 # 若干先前發展的材料難以施用與維持接觸創傷部位。 此外’爲了由傷口去除此等材料經常需要灌洗傷口。若投 予之材料量造成不適或灼傷’則傷口需要即刻沖洗。於傷 者或受傷動物尙未能運送至可提供所需灌洗之設施之情況 下’可能導致傷口之非期望效應或傷口之過度處理。 手術過程中，出血也成問題。除了縫合或釘合切開部 或內部出血區之外，出血經常係使用泡綿或其它材料來朝 向出血部位施加壓力及/或吸收血液。但當過度出血時，此 200831144 等措施不足以停止血液的流動。此外，任何高度 血控制材料可能損傷出血部位周圍組織，可能爲 容易移除的狀態。 基於前文說明，本發明之大致目的係提供一 或改良與先前技術相關聯之缺點之止血劑。本發 大致目的係提供可施加此等止血劑之裝置。 【發明內容】 I 根據一個態樣，本發明係關於一種呈顆粒形 劑。各個顆粒包含一第一成分以及連結於其上之 分，各個成分具有止血性質。也可包括額外成分 分（或全部成分）係均勻且均質定量混合來調節當 施用於出血時之放熱反應。當使用止血劑來處理 口時，出血傷口接觸該止血劑，造成由該出血傷 血液凝固。 根據另一態樣，本發明係關於一種促進血液 % 置。該裝置包含一容器用來保留呈顆粒形式之一 其中，該容座（receptacle)之至少一部分係由一具 篩網所界限。該止血劑包含顆粒，各個顆粒具有 性質之第一成分以及也具止血性質之一第二成分 成分連結該第一成分。該第一成分與該第二成分 勻且均質混合來當該止血劑施用於出血時調節放 當治療出血傷口時，該裝置的施用造成至少部分 觸流經開口的血液。 放熱之出 使用後不 種可克服 明也有一 式之止血 一第二成 。兩種成 該止血劑 出血的傷 口流出的 凝固之裝 止血劑於 有開口之 一具止血 ，該第二 係定量均 熱反應。 止血劑接 200831144 根據另一態樣，本發明係關於一種控制出血 於此種態樣中，襯墊包含一篩網結構，係由其尺 液流經其中之開口所界定，也由止血劑保留於篩 所界定。止血劑包含顆粒’各個顆粒具有一具止 第一成分以及也具止血性質之一第二成分，該第 結該第一成分。該第一成分與該第二成分係定量 質混合，來當該止血劑施用於出血時調節放熱反 療出血傷口時，該襯墊的施用造成至少部分止血 經開口的血液。 根據另一態樣，本發明係關於一種可施用於 口之繃帶。該繃帶包含一基材，安裝於該基材上之 及保留於該篩網內部之一止血劑。該篩網係由多 界定開口之構件所界定，該等開口之尺寸係允許 其中。止血劑包含顆粒，各個顆粒具有一具止血 一成分以及也具止血性質之一第二成分，該第二 • 該第一成分。該第一成分與該第二成分係定量均 混合來當該裝置施用於一出血傷口且當止血劑與 時，可調節放熱反應。 於此處揭示之止血劑及裝置之較佳具體例中 分例如可爲沸石，第二成分例如可爲黏土，諸如 當於此處所述之具體例中之第一成分及第二 爲沸石及黏土時’本發明之一項優點爲沸石成分 成分比較單獨使用沸石與血液造成較少放熱反應 之襯墊。 寸允許血 網結構內 血性質之 二成分連 均勻且均 應。當治 劑接觸流 一出血傷 :一筛網， 個配置來 血液流經 性質之第 成分連結 勻且均質 血液接觸 ，第一成 高嶺土。 成分分別 組合黏土 。特別， 200831144 黏土的存在，經由減少由血液中過度激烈抽取水分，因而 緩和於傷口部位所經驗的放熱效應。理論上較少從血液中 抽取水分是由於水分較少從傷口快速移轉的結果。但止血 劑之多孔本質仍然允許水分被芯吸遠離，造成血液的稠度 增加，因而有助於凝血的形成。 另一項優點爲本發明之止血劑比較全部爲黏土材料或 實質上全部黏土材料於血液產生更多放熱反應。小量熱可 協助凝固血液的過程。如此，經由摻混成比例數量之可連 同黏土而與血液產生放熱反應之一種成分（例如沸石），熱 的總量可經過調節，若千數量之熱可能合乎期望地產生來 協助血液的凝固。 另一項優點爲止血劑之止血性質可依據手邊的需要 「調整」。此項調整容易經由改變止血劑中個別成分之比 例來止血。更特別，沸石相對於黏土之數量可經調整來控 制於傷口部位所產生之熱量。控制於傷口部位之熱量可用 φ 來治療某些病人諸如小兒科病人或老年病人，或用於接受 處理的傷口爲特別敏感區域或特別纖細區域時。 本發明之又另一優點爲本發明之止血劑及裝置容易施 用至開放性傷口。特別當止血劑保留於一篩網或類似裝置 內時，裝置容易由無菌包裝中移除，直接放置或固定於出 血點來引發凝血。 【實施方式】 此處揭示可施用於出血傷口來促進止血之止血裝置及 200831144 止血劑。止血劑通常包括定量具有止血性質之顆粒，此等 顆粒係容納於網袋、穿孔容器、或類似之裝置內部，此等 顆粒當與出血傷口接觸時，經由吸收至少部分血液的液 相，減少或停止血液的流動，藉此來協助凝血。各個顆粒 包括一分子篩材料成分及一黏結劑材料成分。該等顆粒非 僅限於二成分式混合物，其它成分（例如抗感染劑等）也可 含括作爲第三成分或隨後之各成分。 於一個較佳具體例中，分子篩材料爲沸石，黏結劑成 分爲具有止血性質之材料。此處揭示之止血裝置之止血劑 非僅限於沸石，其它分子篩材料也屬於本發明之範圍。 如此處使用，「沸石」一詞係指有一種或多種離子諸 如鈣部分及鈉部分之鋁矽酸鹽結晶形式，且具有脫水能力 而不會造成結晶結構的改變。典型地，沸石爲除了水之外 包括鈣、鈉、鋁及矽之氧化物之脆性材料。鈣部分含有尺 寸約爲5埃之晶體，鈉部分含有尺寸約4埃之晶體。沸石 φ 之較佳分子結構爲^ A型」晶體，換言之，有界限圓形開 口或實質上圓形開口之立方結晶結構之晶體。一種較佳沸 石標示爲「5 A」，指示晶體大小約5埃，具有界限圓形開 口或實質上圓形開口之立方結晶結構。 用於所揭示用途之沸石爲天然沸石或合成製造沸石。 發現多種天然沸石於澱積環境下以及於其它位置呈沈積 物。可應用於此處所述組成物之天然沸石包括但非限於方 沸石、菱沸石、片沸石、鈉沸石、銻沸石（stilbite)、及湯 -10- 200831144 姆沸石（t h 〇 m 〇 s ο n i t e)。也可用於此處所述組成物及方法之合 成製造之沸石通常係經由其中稀土氧，化物經以矽酸鹽取 代，鋁氧、或鋁氧與鹼金屬氧化物或鹼土金屬氧化物之組 合取代之方法製造。 較佳黏結劑爲具有適當止血性質之黏土。但此處揭示 之止血裝置之止血劑非僅限於黏土，其它材料也屬於本發 明之範圍。例如生物活性玻璃、含矽氧化物、矽藻土及其 組合也可用於替代（或添加）黏土。 如此處使用，「黏土」一詞係指水合矽酸鋁之結晶形 式。黏土晶體具有不規則形狀且不溶於水。某些類型黏土 與水的組合可產生有某種程度塑性之物質。依據黏土類型 而定，黏土與水之組合可產生具有觸變性質之膠體凝膠。 於本發明之止血劑及裝置中所使用之黏土較佳爲高嶺 土，高嶺土爲包含約50%鋁氧，約50%矽氧及微量雜質之 層狀矽酸鋁。黏土可爲愛德格（E d g a r)塑性高嶺土（後文縮寫 φ 爲「EPK」），EPK爲於美國佛羅里達州愛德格及其附近採 礦與加工之經過水洗之高嶺土黏土。愛德格塑性高嶺土具 有期望之塑性性質，可鑄塑，愛德格塑性高嶺土當混合水 時製造觸變性料漿。其它黏土諸如鎂質膨潤土及膨潤土也 屬於本發明之範圍，可個別使用、彼此組合使用或與高嶺 土組合使用。 本發明所使用之EPK爲顆粒化、經乾燥且經過粉化。 爲了達成EPK之適當均質混合物供隨後轉換成爲粉末，使 200831144 用適當混合裝置施加相對高切變之EPK質塊。於切變前， 測定黏土之水含量，且調整至約20%重量比，來獲得供擠 塑以及隨後加工處理之可充分加工混合物。然後ΕΡΚ加工 成爲濾餅且於烤爐內乾燥。當乾燥至適當水分含量時，隨 後濾餅被軋碎成爲粉末。 沸石/黏土顆粒可藉多種不同方法中之任一種製造。此 等方法包括混合、擠塑、球體化等。可用於將黏土混合、 _ 擠塑或球體化之設備可得自卡里發加工溶液公司（Caleva Process Solutions Ltd·)，英國朵賽特（Dorest， United Kmgdom)。其它方法包括使用流體床或造粒裝置。用於製 造顆粒之流體床可得自葛拉特空氣技術公司（Glatt Ah Technologies)於紐澤西州拉姆希。製造黏土顆粒之圓盤狀 造粒機可得自菲可國際公司（Fee co International，Inc·)，威 斯康辛州格林灣。較佳，沸石與黏土之混合物通過適當造 粒裝置擠塑。本發明非僅囿限於此一方面，其它止血劑顆 φ 粒之製造裝置及方法也述於本發明之範圍。 如此處使用，止血劑「顆粒」包括珠粒、九粒、圓粒、 桿狀或任何其它表面形狀或表面形狀的組合。與表面形狀 無關，沸石/黏土顆粒之有效直徑約爲0.2毫米至約10毫 米，較佳約0.5毫米至約5毫米，及更佳約1毫米至約2 毫米。 於本發明之若干具體例中，沸石/黏土顆粒可燒製至約 600 °C來玻璃化黏土部分。玻璃化係透過重複溶解與冷卻週 -12- 200831144 期循環執行，允許EPK (或其它黏土材料）轉換成玻璃狀物 質。週期數目增加，結晶結構崩潰，獲得非晶形組成物。 ΕΡΚ之非晶形本質允許於隨後’濕潤時維持其結構完好。結 果，ΕΡΚ可對抗使用期間濕潤時例如施用於血液時崩解的 傾向。於其中於玻璃化前，沸石與ΕΡΚ混合之具體例中， 沸石不會受到顆粒之加熱與冷卻的影響。 於其它具體例中，可預先進行玻璃化程序，來獲得柔 軟疏鬆塡充之脆性顆粒。各個顆粒以沸石及黏土塡充，允 許當施用於血液時黏土部分粉碎，藉此將沸石與黏土二者 分散遍布傷口。 相信沸石及黏土二者之細胞凝固機轉當施用於血液時 可活化某些接觸因子。特別，相信沸石及高嶺土（特別爲ΕΡΚ) 爲不同但互補。雖然各種材料本身具有止血性質，但可能 各自分子結構的差異引發不同的機轉，藉此機轉血液中之 水分被吸收而協助凝血功能。 與沸石及黏土之凝血機轉獨立無關，於調配用於止血 裝置之止血劑時，沸石與黏土摻混且粒化來製造具有可生 物相容態樣之放熱材料與非放熱材料之均勻均質混合物。 顆粒中之沸石及黏土之用量經選擇來當顆粒施用於出血傷 口時提供特殊放熱。各成分數量的改變允許止血劑施用於 出血傷口時所產生的熱量依據所需調整。 止血劑之沸石/黏土顆粒可與具有脫水能力但不會造 成結晶結構顯著變化，同時對止血劑提供有利性質之其它 -13- .200831144 材料混合、摻混或以其它方式結合。此等材料包括但非限 於硫酸鎂、偏磷酸鈉、氯化鈣、糊精、前述各種材料之組 合及前述各種材料之水合物。 多種其它材料也可與止血劑之沸石/黏土混合物混 合、結合或摻混入其中來維持傷口部位之無菌環境，或提 供可補充沸石及黏土之凝血功能之功能。可使用之材料實 例包括但非限於醫藥活性組成物諸如傷口癒合劑、抗生 素、抗真菌劑、抗感染劑、抗微生物劑、抗炎劑、止痛劑、 抗組織胺（例如希美提定（cimetidine)、克洛菲尼拉明 (c h 1 〇 r 〇 p h e n i r a m i n e)順丁烯二酸鹽、待芬海卓明 (diphenhydramine)鹽酸鹽、及波美雜今（promethazine)鹽酸 鹽）、含有銀離子及/或銅離子之化合物等。可摻混來提供 額外止血功能之其它材料包括抗壞血酸、凝血酸 (tranexamic acid)、芸香昔（rutin)及凝血酶。也可添加對傷 口部位具有期望功效之本草藥劑。 現在參考第1圖，顯示其中摻混止血劑之止血裝置。 該止血裝置爲通透性囊袋’允許液體進入來接觸其中所保 留的止血劑。密封包裝（圖中未顯示）提供至使用前儲存止 血裝置之無菌環境。止血裝置大致上顯示於10，後文稱作 爲「囊袋」10包含一篩或網12以及藉該篩或網保留於其中 之止血劑1 4。篩網1 2之各個側邊被封閉而界限出一個可將 止血劑1 4保留於其中同時允許液體流經其中之開口。如圖 所示，篩網1 2顯示爲扁平，而只顯示數個止血劑1 4顆粒。 -14- 200831144 如此處所述，止血劑14包含沸石及黏土（或其它止血材料） 顆粒。 篩網1 2係由互連之材料股線、纖絲或長條所界限。股 線、纖絲或長條可以任一種方式或多種方式之組合方式互 連，包括但非限於編織成紗布、交纏、一體成形等。較佳 交互連接讓篩網爲可撓性，同時實質上維持藉該篩網所界 定之開口的尺寸。製造股線、纖絲或長條之材料可爲聚合 物（例如尼龍、聚乙烯、聚丙烯、聚酯等）、金屬、玻璃纖 ^ 維、或有機物質（例如棉、毛、絲等）。 現在參考第2圖，由篩網12所界定之開口之尺寸可保 有止血劑14，但允許血液流經其中。由於篩網12可包住止 血劑14拉緊，顆粒可通過開口延長距離d。若顆粒通過開 口延長，則顆粒可直接接觸囊袋1 0所施用之組織。如此， 由組織流出之血液即刻接觸止血劑1 4，血液之水相被芯吸 至沸石及黏土材料內部，因而有助於血液的凝固。但本發 φ 明並未要求顆粒通過篩網突出。 欲將囊袋10施用至出血傷口，囊袋由包裝中取出，放 置於出血傷口上。篩網1 2中之止血劑1 4接觸傷口組織及/ 或血液，至少部分血液之液相被顆粒的沸石及黏土所吸 收，藉此促進血液的凝固。 本發明之另一個具體例爲參照第3圖顯示於20之一個 襯墊，於後文稱作爲「襯墊20」。襯墊20包含篩網12、 由篩網12保留於其中之止血劑14、以及於襯墊20施用至 •15- 200831144 出血傷口時可施加壓力之一撐體22。如前述，篩網12具 可將顆粒保留於其中同時允許血液流經其間之開口。 篩網1 2經縫綴、經膠黏、經夾緊、或以其它方式安 \ 於撐體22時。撐體22包含一底面2 4,止血劑14係藉容 12而固定於底面及一頂面26。底面24對止血劑14爲不 性（防止顆粒遷移入撐體22內部），進一步可對抗水或其 流體的吸收。經由施加襯墊20至出血傷口或藉頂面26 所支載的重量，頂面26可有壓力施加於其上。整個撐體 爲剛性或半剛性，允許施加壓力同時減少對病人造成的 適。 欲施加襯墊20至出血傷口，將襯墊20由包裝中取 及放置於出血傷口上。如同第1圖及第2圖之具體例之 . 袋，止血劑1 4直接接觸傷口組織或直接接觸血液。且以 加壓於頂面26或藉放置重量於表面上可施加壓力於 口’鞯此協助顆粒與傷口間的接觸且促進血液中液相的 鲁 收。襯墊20 (有重量或未施加重量）也可使用捆紮裝置諸 帶狀物、彈性裝置、鉤與環材料、前述裝置與材料之組 等而固定於傷口上。 現在參考第4圖，本發明之另一個具體例爲繃帶， 帶顯示於50，包含止血劑14顆粒保留於篩網12內部且 ▲至可施用至傷口之可燒性基材5 2 (例如使用感_黏著 來將繃帶50黏著至配用者皮膚）。篩網12經縫綴、經膠 或以其它方式安裝至基材52來形成繃帶50。 有 裝 器 透 它 上 22 不 出 囊 手 傷 吸 如 合 繃 ‘安 :劑 [黏 -16· 200831144 基材52爲塑膠構件或布構件，其適合維持於受傷者或 受傷動物皮膚上與出血傷口上或出血傷口附近·。黏著劑54 設置於接合受傷者或受傷動物皮膚之基材52之表面上。特 別若基材5 2是無法呼吸之塑膠材料，則基材可包括孔隙5 6 來允許水分由皮膚表面耗散。 雖然已經就詳細具體例顯示及說明本發明，但熟諳技 藝人士須了解可做出多項變化，可未悖離本發明之範圍以 相當元件來取代其元件。此外，可未悖離其主要範圍做出 ® 修改來讓特定情況或材料配合本發明之教示。因此，預期 本發明非僅限於前文詳細說明揭示之具體例，反而本發明 涵蓋全部落入於隨附之申請專利範圍之具體例。 【圖式簡單說明】 第1圖爲本發明之血液凝固裝置之示意代表圖。 第2圖爲第1圖之血液凝固裝置之側視圖，顯示分子 篩顆粒保有於一篩網容器內部。 φ 第3圖爲一加壓襯墊之側視圖，該加壓襯墊結合分子 篩顆粒囊封於一篩網容器內用來加壓施用於一出血傷口。 第4圖爲一繃帶之透視圖，該繃帶結合分子篩顆粒於 一篩網容器用來施用於出血傷口。 【主要元件符號說明】 - 10 囊袋 • 12 篩網 14 止血劑 -17- 200831144 20 襯墊 22 撐體 24 底面 26 頂面 50 繃帶 52 基材 54 黏著劑 56 孔隙W Particles The surface area of the material often produces an exothermic reaction when the material is applied to the bleeding site. Excessive material is often poured onto the wound unnecessarily, causing a deterioration in the exothermic effect. Depending on the specific properties of the material, the resulting exotherm may be sufficient to cause discomfort or even fever. While a number of prior art patents specifically recite the resulting exothermic response as a desirable feature, a similar coagulation effect can be produced on the wound, but it is still possible that the wound site tissue and surrounding tissue are adversely affected. # Several previously developed materials are difficult to apply and maintain contact with the wound site. Furthermore, it is often necessary to lavage wounds in order to remove such materials from the wound. If the amount of material administered causes discomfort or burns, the wound needs to be rinsed immediately. In the event that the injured or injured animal fails to be transported to a facility that provides the required lavage, it may cause undesired effects of the wound or excessive treatment of the wound. Bleeding is also a problem during surgery. In addition to suturing or stapling the incision or internal bleeding area, bleeding often uses foam or other materials to apply pressure and/or absorb blood to the bleeding site. However, when excessive bleeding occurs, this measure such as 200831144 is not enough to stop the flow of blood. In addition, any high blood control material may damage the tissue surrounding the bleeding site and may be in an easily removable condition. Based on the foregoing description, it is a general object of the present invention to provide a hemostatic agent that improves or disadvantages associated with the prior art. The general purpose of the present invention is to provide a device for applying such hemostatic agents. SUMMARY OF THE INVENTION According to one aspect, the present invention is directed to a particulate form. Each particle comprises a first component and a component attached thereto, each component having a hemostatic property. Additional components (or all components) may also be included in a homogeneous and homogeneous quantitative mix to modulate the exothermic response when applied to bleeding. When a hemostatic agent is used to treat the mouth, the bleeding wound contacts the hemostatic agent, causing blood to clot from the bleeding. According to another aspect, the invention relates to a blood-promoting arrangement. The device comprises a container for retaining one of the particulate forms wherein at least a portion of the receptacle is bounded by a screen. The hemostatic agent comprises particles, each of the particles having a first component of a nature and one of the hemostatic properties also having a second component associated with the first component. The first component is uniformly and homogeneously mixed with the second component to provide for at least partial flow of blood through the opening when the hemostatic agent is administered to hemorrhage to adjust to treat the bleeding wound. Exothermic heat can not be overcome after use. There is also a type of hemostasis in the second. Two kinds of hemostatic agents are bleeding from the wound, and the hemostatic agent is hemostasis in the opening, and the second system is quasi-thermally reactive. Hemostatic agent is connected to 200831144. According to another aspect, the invention relates to a method of controlling bleeding in a pattern comprising a screen structure defined by an opening through which a sizing fluid flows, and also retained by a hemostatic agent Defined by the sieve. The hemostatic agent comprises particles 'each particle having a first component and a second component also having a hemostatic property, the first component being first. The first component is quantitatively mixed with the second component to provide an at least partial hemostasis of the transfused blood when the hemostatic agent is applied to the hemorrhage to modulate the exothermic recurrent bleeding wound. According to another aspect, the present invention is directed to a bandage that can be applied to the mouth. The bandage comprises a substrate, a hemostatic agent mounted on the substrate and retained within the screen. The screen is defined by a plurality of members defining the opening, the dimensions of which are permitted. The hemostatic agent comprises granules, each granule having a hemostatic component and a second component also having hemostatic properties, the second component. The first component and the second component are both quantitatively mixed to adjust the exothermic reaction when the device is applied to a bleeding wound and when the hemostatic agent is present. Preferred examples of the hemostatic agent and device disclosed herein may be, for example, a zeolite, and the second component may be, for example, clay, such as the first component and the second zeolite in the specific examples described herein and In the case of clay, an advantage of the present invention is that the composition of the zeolite component is compared to the liner which causes less exothermic reaction between the zeolite and the blood. The inch allows the two components of the blood properties within the blood network structure to be even and uniform. When the agent contacts the flow of a hemorrhagic injury: a sieve, a configuration to the flow of blood through the first component of the property is even and homogeneous blood contact, the first into kaolin. The ingredients are combined with clay. In particular, the presence of clay in 200831144, by reducing the excessively intense extraction of water from the blood, thus alleviating the exothermic effects experienced in the wound site. Theoretically less water is drawn from the blood as a result of less rapid water transfer from the wound. However, the porous nature of the hemostatic agent still allows the moisture to be wicked away, resulting in an increase in the consistency of the blood, thereby contributing to the formation of blood clotting. Another advantage is that the hemostatic agent of the present invention produces more exothermic reactions in the blood than all of the clay material or substantially all of the clay material. A small amount of heat can assist in the process of coagulation of blood. Thus, by mixing a component (e.g., zeolite) that produces an exothermic reaction with blood in a proportionate amount of coherent clay, the total amount of heat can be adjusted if a thousand amounts of heat may be desirably produced to assist in the coagulation of the blood. Another advantage is that the hemostatic properties of the blood agent can be "adjusted" according to the needs at hand. This adjustment is easy to stop by changing the ratio of individual components of the hemostatic agent. More specifically, the amount of zeolite relative to the clay can be adjusted to control the amount of heat generated at the wound site. The heat that is controlled at the wound site can be treated with φ to treat certain patients, such as pediatric patients or elderly patients, or when the treated wound is a particularly sensitive area or a particularly delicate area. Yet another advantage of the present invention is that the hemostatic agents and devices of the present invention are readily applied to open wounds. Particularly when the hemostatic agent remains in a screen or the like, the device is easily removed from the sterile package and placed directly or fixed at the point of bleeding to initiate coagulation. [Embodiment] A hemostatic device that can be applied to a bleeding wound to promote hemostasis and a hemostatic agent of 200831144 are disclosed herein. Hemostatic agents typically comprise a plurality of granules having hemostatic properties which are contained within a mesh bag, perforated container, or the like, which, when in contact with the bleeding wound, are reduced by the absorption of at least a portion of the blood phase of the liquid, or Stop the flow of blood to help coagulate. Each particle comprises a molecular sieve material component and a binder material component. The particles are not limited to the two-component mixture, and other components (e.g., anti-infective agents, etc.) may also be included as the third component or subsequent components. In a preferred embodiment, the molecular sieve material is zeolite and the binder component is a material having hemostatic properties. The hemostatic agent of the hemostatic device disclosed herein is not limited to zeolites, and other molecular sieve materials are also within the scope of the invention. As used herein, the term "zeolite" refers to a crystalline form of aluminosilicate having one or more ions such as a calcium moiety and a sodium moiety, and which has a dehydrating ability without causing a change in crystal structure. Typically, the zeolite is a brittle material including oxides of calcium, sodium, aluminum and cerium other than water. The calcium portion contains crystals having a size of about 5 angstroms, and the sodium portion contains crystals having a size of about 4 angstroms. The preferred molecular structure of the zeolite φ is a crystal of the type A, in other words, a crystal having a cubic opening structure or a cubic crystal structure having a substantially circular opening. A preferred zeolite is designated "5 A", indicating a crystal size of about 5 angstroms having a cubic crystal structure with a defined circular opening or a substantially circular opening. The zeolites used in the disclosed applications are natural zeolites or synthetically produced zeolites. A variety of natural zeolites have been found to deposit in the deposition environment as well as at other locations. Natural zeolites useful in the compositions described herein include, but are not limited to, analcite, chabazite, flaky zeolite, sodium zeolite, stilbite, and soup-10-200831144 ymite (th 〇m 〇s ο nite) ). Synthetic zeolites which can also be used in the synthesis of the compositions and methods described herein are typically replaced by a combination of rare earth oxygen, a silicate, an aluminum oxide, or a combination of an aluminum oxide and an alkali metal oxide or an alkaline earth metal oxide. The method of manufacture. Preferred binders are clays having suitable hemostatic properties. However, the hemostatic agent of the hemostatic device disclosed herein is not limited to clay, and other materials are also within the scope of the present invention. For example, bioactive glass, cerium-containing oxide, diatomaceous earth, and combinations thereof can also be used to replace (or add) clay. As used herein, the term "clay" refers to the crystalline form of hydrated aluminum silicate. Clay crystals have an irregular shape and are insoluble in water. The combination of certain types of clay with water produces a substance that has some degree of plasticity. Depending on the type of clay, the combination of clay and water produces a colloidal gel with thixotropic properties. The clay used in the hemostatic agent and device of the present invention is preferably kaolin. The kaolin is a layered aluminum silicate containing about 50% aluminum oxide, about 50% helium oxygen and trace impurities. The clay may be Edg (a) plastic kaolin (hereinafter abbreviated as "EPK"), and EPK is a washed kaolin clay that is mined and processed in and around Edgar, Florida, USA. Edgar plastic kaolin has the desired plastic properties and can be cast. Edgar plastic kaolin is a thixotropic slurry when mixed with water. Other clays such as magnesia bentonite and bentonite are also within the scope of the invention and may be used individually, in combination with each other or in combination with kaolin. The EPK used in the present invention is granulated, dried and pulverized. In order to achieve a suitable homogeneous mixture of EPK for subsequent conversion to a powder, use 200831144 to apply a relatively high shear EPK mass with a suitable mixing device. Prior to shearing, the water content of the clay was determined and adjusted to about 20% by weight to obtain a fully processable mixture for extrusion and subsequent processing. The crucible is then processed into a filter cake and dried in an oven. When dried to the appropriate moisture content, the filter cake is then crushed into a powder. Zeolite/clay particles can be made in any of a variety of different ways. These methods include mixing, extrusion, spheroidization, and the like. Equipment that can be used to mix, _extrude or spheroidize clay is available from Caleva Process Solutions Ltd., Dorest, United Kmgdom. Other methods include the use of fluid beds or granulation devices. The fluid bed used to make the granules is available from Glatt Ah Technologies in Ramsey, New Jersey. A disc-shaped granulator for making clay granules is available from Fee Co International, Inc., Green Bay, Wisconsin. Preferably, the mixture of zeolite and clay is extruded by a suitable granulation unit. The present invention is not limited to this aspect, and other apparatus and method for producing a hemostatic agent granule are also described in the scope of the present invention. As used herein, a hemostatic "particle" includes beads, nine, rounds, rods, or any other combination of surface shapes or surface shapes. Irrespective of the shape of the surface, the effective diameter of the zeolite/clay particles is from about 0.2 mm to about 10 mm, preferably from about 0.5 mm to about 5 mm, and more preferably from about 1 mm to about 2 mm. In several embodiments of the invention, the zeolite/clay particles can be fired to a temperature of about 600 ° C to the vitrified clay portion. The vitrification system is cycled through repeated dissolution and cooling cycles -12-200831144, allowing EPK (or other clay material) to be converted to a glassy substance. As the number of cycles increases, the crystal structure collapses, and an amorphous composition is obtained. The amorphous nature of the crucible allows it to remain intact when wet. As a result, sputum can counteract the tendency to disintegrate when applied during application, for example, when applied to blood. In the specific example in which the zeolite is mixed with cerium before vitrification, the zeolite is not affected by the heating and cooling of the particles. In other specific examples, the vitrification procedure can be carried out in advance to obtain soft, loose and crunchy brittle particles. The individual particles are impregnated with zeolite and clay, allowing the clay to partially comminute when applied to the blood, thereby dispersing both the zeolite and the clay throughout the wound. It is believed that the cell coagulator of both zeolite and clay can activate certain contact factors when applied to blood. In particular, it is believed that zeolites and kaolins (especially strontium) are different but complementary. Although the various materials themselves have hemostatic properties, it is possible that the difference in their respective molecular structures triggers different mechanisms of rotation, whereby the water in the blood is absorbed to assist in the coagulation function. Irrespective of the coagulation of zeolite and clay, when blended with a hemostatic agent for a hemostatic device, the zeolite is blended with the clay and granulated to produce a homogeneous homogeneous mixture of exothermic and non-exothermic materials with a biocompatible form. The amount of zeolite and clay in the granules is selected to provide a particular exotherm when the granules are applied to the bleeding wound. The change in the amount of each component allows the heat generated by the application of the hemostatic agent to the bleeding wound to be adjusted as desired. The zeolite/clay particles of the hemostatic agent can be mixed, blended or otherwise combined with other materials having dehydrating power without significantly altering the crystalline structure while providing advantageous properties to the hemostatic agent. Such materials include, but are not limited to, magnesium sulfate, sodium metaphosphate, calcium chloride, dextrin, combinations of the foregoing various materials, and hydrates of the foregoing various materials. A variety of other materials can also be mixed, combined or blended with the zeolite/clay mixture of the hemostatic agent to maintain the sterile environment of the wound site or provide a function to supplement the coagulation function of the zeolite and clay. Examples of materials that may be used include, but are not limited to, pharmaceutically active compositions such as wound healing agents, antibiotics, antifungals, anti-infectives, antimicrobials, anti-inflammatory agents, analgesics, antihistamines (eg, cimetidine). , clofeniramine (ch 1 〇r 〇pheniramine) maleate, diphenhydramine hydrochloride, and promethazine hydrochloride, containing silver ions And/or a compound of copper ions, and the like. Other materials that can be blended to provide additional hemostatic function include ascorbic acid, tranexamic acid, rutin, and thrombin. It is also possible to add a herbal preparation which has the desired effect on the wound site. Referring now to Figure 1, a hemostasis device incorporating a hemostatic agent is shown. The hemostatic device is a permeable pouch' that allows liquid to enter to contact the hemostatic agent retained therein. A sealed package (not shown) provides a sterile environment for storing the hemostatic device prior to use. The hemostasis device is shown generally at 10, hereinafter referred to as a "pouch" 10 comprising a screen or mesh 12 and a hemostatic agent 14 retained therein by the screen or mesh. The sides of the screen 12 are closed to define an opening in which the hemostatic agent 14 is retained while allowing liquid to flow therethrough. As shown, the screen 1 2 is shown as flat, and only a few hemostatic agents 14 particles are shown. -14- 200831144 As described herein, the hemostatic agent 14 comprises zeolite and clay (or other hemostatic material) particles. The screen 12 is bounded by interconnected strands of material, filaments or strips. The strands, filaments or strips may be interconnected in any manner or in a combination of ways including, but not limited to, weaving into gauze, interlacing, integral forming, and the like. Preferably, the interactive connection allows the screen to be flexible while substantially maintaining the size of the opening defined by the screen. The material from which the strands, filaments or strips are made may be a polymer (e.g., nylon, polyethylene, polypropylene, polyester, etc.), a metal, a glass fiber, or an organic material (e.g., cotton, wool, silk, etc.). Referring now to Figure 2, the opening defined by the screen 12 is sized to retain the hemostatic agent 14, but allows blood to flow therethrough. Since the screen 12 can encase the hemostatic agent 14 in tension, the particles can extend the distance d through the opening. If the granules are extended through the opening, the granules can directly contact the tissue to which the capsular bag 10 is applied. Thus, the blood flowing out of the tissue is immediately contacted with the hemostatic agent 14 and the aqueous phase of the blood is wicked into the interior of the zeolite and the clay material, thereby contributing to the coagulation of the blood. However, this method does not require particles to protrude through the screen. To apply the pouch 10 to the bleeding wound, the pouch is removed from the package and placed on the bleeding wound. The hemostatic agent 14 in the screen 12 contacts the wound tissue and/or blood, and at least part of the blood phase is absorbed by the particles of zeolite and clay, thereby promoting blood coagulation. Another specific example of the present invention is shown in Fig. 3 as a spacer of 20, which will hereinafter be referred to as "pad 20". The liner 20 comprises a screen 12, a hemostatic agent 14 retained therein by the screen 12, and a support 22 that can be applied when the liner 20 is applied to the bleeding wound of the period 15-15. As previously mentioned, the screen 12 has openings in which particles can be retained while allowing blood to flow therethrough. The screen 1 2 is sewn, glued, clamped, or otherwise secured to the support 22. The support 22 includes a bottom surface 24, and the hemostatic agent 14 is attached to the bottom surface and a top surface 26 by the volume 12. The bottom surface 24 is insensitive to the hemostatic agent 14 (preventing migration of particles into the interior of the support 22) and is further resistant to absorption by water or its fluid. The top surface 26 can be pressure applied thereto by applying the liner 20 to the bleeding wound or by the weight carried by the top surface 26. The entire support is rigid or semi-rigid, allowing pressure to be applied while reducing the fit for the patient. To apply the pad 20 to the bleeding wound, the pad 20 is placed from the package on the bleeding wound. As in the specific examples of Figures 1 and 2, the bag, the hemostatic agent 14 directly contacts the wound tissue or directly contacts the blood. Pressurizing the top surface 26 or placing a weight on the surface can apply pressure to the mouth to assist the contact between the particles and the wound and promote the elimination of the liquid phase in the blood. The liner 20 (with or without weight) can also be secured to the wound using strapping device strips, elastic means, hook and loop materials, a combination of the foregoing devices and materials, and the like. Referring now to Figure 4, another embodiment of the present invention is a bandage, the tape being shown at 50, containing particles of hemostatic agent 14 remaining inside the screen 12 and ▲ to an flammable substrate 52 that can be applied to the wound (e.g., using Sense_adhesive to adhere the bandage 50 to the wearer's skin). The screen 12 is sewn, glued or otherwise mounted to the substrate 52 to form the bandage 50. There is a device on it, 22 does not have a hand injury, such as a stretch of 'An: agent [stick-16· 200831144 substrate 52 is a plastic component or cloth component, which is suitable for maintaining the wounded or injured animal skin and bleeding wounds On or near the bleeding wound. Adhesive 54 is disposed on the surface of substrate 52 that joins the skin of the injured or injured animal. In particular, if the substrate 52 is a plastic material that is not breathable, the substrate may include apertures 56 to allow moisture to be dissipated by the skin surface. Although the present invention has been shown and described with respect to the specific embodiments thereof, it is understood by those skilled in the art that various changes can be made without departing from the scope of the invention. In addition, ® modifications may be made without departing from the spirit and scope of the invention. Therefore, the invention is not intended to be limited to the specific examples disclosed in the foregoing detailed description. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic representation of a blood coagulation device of the present invention. Figure 2 is a side elevational view of the blood coagulation device of Figure 1 showing the molecular sieve particles retained within a mesh container. φ Figure 3 is a side view of a pressurized liner in combination with molecular sieve particles encapsulated in a mesh container for application to a bleeding wound under pressure. Figure 4 is a perspective view of a bandage incorporating molecular sieve particles in a mesh container for application to a bleeding wound. [Main component symbol description] - 10 pouches • 12 screens 14 Hemostatic agents -17- 200831144 20 Pads 22 Supports 24 Bottom surface 26 Top surface 50 Bandages 52 Substrate 54 Adhesives 56 Pores
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